Biotechnology: Delays in and Status of EPA's Efforts to Issue a TSCA Regulation

摘要

This report responds to your April 11,1991, request for information on thedevelopment and potential issuance of a biotechnology regulation under the Toxic Substances Control Act (TscA) to control certain genetically modified mIcroorganisms used in commerce. Specifically, you asked us to address (1) the Environmental Protection Agency's (EPA) efforts to issue a TSCA biotechnology regulation and (2) the impact on the biotechnology industry of not havIng a TSCA biotechnology regulation. Biotechnology has the potential to dramatically improve the health of humans and animals, the food supply, and the environment. In this process, new vaccines, pesticides, insect-resistant plants, bacteria that break down toxic wastes, and other products and services can be created by applying biological procedures, such as genetic engineering, to living organisms or their components. However, safeguards are needed to ensure that the release of these organisms created by biotechnology does not pose an unreasonable risk to public health or the environment. TSCA was enacted in October 1976 to provide a safeguard against the introduction of harmful new chemicals into the environment and to address the risks posed by chemicals already in use. EPA considers microorganisms and their component parts used in biotechnology products to be chemical substances and thus subject to regulation under the act.